Characterizing the Use of Ofatumumab in a Real World Setting

NCT05090033 | Completed

• 1 other identifier: COMB157GAU01
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 7

Brief Summary

This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes.

Conditions

Relapsing Multiple Sclerosis

Keywords

ofatumumab; NIS; RMS

Outcome Measures

Primary Outcomes (2)

• Part I and II: Proportion of doses not completed within three days of the expected date

  Proportion of doses not completed within three days of the expected date during initiation to be collected

  Initiation

• Part I and II: Proportion of doses not completed within 3 days of the expected date

  Proportion of doses not completed within 3 days of the expected date during the first three months of maintenance to be collected

  First 3 months of maintenance

Secondary Outcomes (19)

• Part I: Proportion of doses not completed within three days of the expected date

  initiation period plus 12 months of maintenance

• Part I: Proportion of doses not completed within 14 days of the expected date

  12 months of maintentance

• Part I: Proportion of participants with a treatment interruption of more than six months during maintenance

  Up to 18 months

• Part I: Proportion of participants discontinued within three months of the intial dose

  Up to 18 months

• Part I: Proportion of participants discontinued within 12 months of the intial dose.

  Up to 18 months

Study Arms (2)

Part I study cohort

Retrospective data analysis of up to 1500 de-identified participants contributing onboarding and adherence data via the MSGo Kesimpta Patient App.

Other: ofatumumab

Part II study cohort

Up to 100 participants responding to PROs via the MSGo Patient App

Other: ofatumumab

Interventions

ofatumumab OTHER

There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Part I study cohort; Part II study cohort

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Australian patients with multiple sclerosis

You may qualify if:

• Adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse
• Expanded Disability Status Scale (EDSS) of 5.5 or lower (aligned with the plannedKEP criteria). Patients accessing ofatumumab through the PBS would have to meet the finalised restriction criteria (to be confirmed).
• Patients will provide consent to participate in Part I of the study through the MSGo experience program or patient support program onboarding process.
• Patients will need to provide additional consent to participate in Part II sub-study.

You may not qualify if:

• Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information\].

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Novartis Investigative Site

Concord, New South Wales, 2139, Australia

Location

Novartis Investigative Site

Southport, Queensland, 4222, Australia

Location

Novartis Investigative Site

Clayton, Victoria, 3168, Australia

Location

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

Location

Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia

Location

Novartis Investigative Site

Heidelberg, 3084, Australia

Location

Novartis Investigative Site

St Leonards, 2065, Australia

Location

MeSH Terms

Interventions

ofatumumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 22, 2021
• Study Start: December 8, 2022
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)